The Law Offices of Timothy L. Miles Informs Investors of a Lawsuit Against Ampio Pharmaceuticals, Inc.
Class action lawsuit charges Ampio Pharmaceuticals and certain of its top executive officers with violations of the Securities Exchange Act of 1934.
Ampio Pharmaceuticals, Inc. (NYSE:AMPE)
If you suffered losses in Ampio, or would like additional information, please visit us here2.
Allegations in the Ampio Class Action Lawsuit
Ampio claims to have developed Ampion®, its lead product purportedly used to treat individuals with inflammatory conditions including, but not limited to, severe osteoarthritis of the knee (“OAK”). In June 2019, Ampio received a Special Protocol Assessment from the U.S. Food and Drug Administration (“FDA”) for an additional Phase III clinical trial titled “A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee” (“AP-013”).The Ampio class action lawsuit alleges that defendants inflated Ampio’s true ability to successfully file a Biologics License Application for Ampion and inflated the results of the AP-013 study and the timing of unblinding the data from the AP-013 study.
On April 20, 2022, Ampio issued a press release providing a regulatory update that the FDA had responded negatively to its Type C meeting request, disclosing the FDA’s conclusion that Ampio “should have sought FDA’s agreement on [certain] changes prior to analyzing and unblinding the data” and “FDA further stated that it did not agree that AP-013 could serve as a second pivotal trial for Ampion based on both the change in the analysis population and the analysis of pain only instead of the original prespecified co-primary endpoints.” On this news, Ampio’s stock price fell by more than 26%.
Then, on May 16, 2022, Ampio announced that an independent special committee of the Board of Directors, with the assistance of independent legal counsel, was in the process of conducting an internal investigation relating to the AP-013 study. On this news, Ampio’s stock price fell an additional 10%.
Finally, on August 3, 2022, Ampio revealed that certain defendants “and senior staff were aware, at the time of the per-protocol interim analysis in March 2020, that the AP-013 trial did not demonstrate efficacy for Ampion on its co-primary endpoints of pain and function; and that these Ampio executive offers and senior staff did not fully report the results of the AP-013 trial and the timing of unblinding of data from the AP-013 trial.” On this news, Ampio’s share price fell by more than 35%, further damaging investors who suffered losses in Ampio stock.
Ampio Shareholders Urged to Contact the Firm
If you purchased Ampio securities, have information, or have any questions concerning this announcement or your rights or interests with respect to these matters, please click here1 for more information or contact Timothy L. Miles, Esquire, at 615-587-7384, Toll-Free at 855-846-6529, or by email to tmiles@timmileslaw.com. If you inquire by email please include your mailing address, telephone number, and the number shares owned.
Timothy Miles
Law Offices Of Timothy L. Miles
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1 https://www.classactionlawyertn.com/ampio-pharmaceuticals.html
2 https://www.classactionlawyertn.com/ampio-pharmaceuticals.htm
3 https://www.classactionlawyertn.com/ampio-pharmaceuticals.html
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